IACM has submitted comments to the docket established by the US Food and Drug Administration (FDA) seeking feedback on its Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food.

Although FDA’s intent may have been to clarify certain terms used in both the fruit and vegetable juice color additive regulations, the practical effect of the draft guidance has been to bind the color industry outside the required notice-and-comment rulemaking process required by the APA. As such, IACM respectfully requested that FDA revoke the draft guidance, which in its current form would disrupt the industry’s ability to produce safe colors derived from fruit juice and vegetable juice.

IACM also requested that FDA remove the summary table listing the informal opinions that FDA has issued over the years in response to industry letters. However, without the context provided by the original inquiries, the table provides incomplete information and creates uncertainty in the regulated community.

IACM offered comment on some key differences in how FDA treats colors derived from fruit juice and vegetable juice as opposed to many of its key trading partners, and which puts the color and food industry at a disadvantage globally by reducing the domestic industry’s ability to innovate and by also creating trade barriers.

Additionally, IACM offered examples of where this guidance is out of line with typical accepted practice, both by industry and other governmental bodies, particularly on the topic of “minimal processing” and provided feedback on the proposed criteria for determination of whether a fruit or vegetable is “edible”